Common bile duct (CBD) stones are a prevalent condition that can lead to severe
complications if left untreated. The standard treatment method involves endoscopic
retrograde cholangiopancreatography (ERCP) for stone removal. Conventional techniques
include sphincterotomy combined with balloon or basket extraction. However, approximately
10-15% of patients present with "difficult CBD stones," which cannot be effectively
removed using standard techniques.
The European Society of Gastrointestinal Endoscopy (ESGE) defines difficult CBD stones as
those meeting one or more of the following criteria: stone size ≥15 mm, impacted stones,
multiple stones, stones in difficult-to-access locations (e.g., intrahepatic or cystic
ducts), barrel-shaped stones, or stones in patients with altered anatomy due to prior
surgical interventions (e.g., Roux-en-Y reconstruction). These cases often require
specialized techniques to achieve successful stone clearance while minimizing
complications.
Intervention and Rationale:
Single-operator cholangioscopy using the SpyGlass system has become a widely adopted
approach for managing difficult CBD stones. This technique enables direct visualization
of the stone and facilitates lithotripsy, which fragments stones into smaller pieces for
easier removal. The two primary lithotripsy techniques available are:
Electrohydraulic Lithotripsy (EHL): Uses shock waves generated by electrical energy
transmitted through a probe to fragment stones.
Laser Lithotripsy (LL): Uses laser energy delivered through a water-mediated medium to
break stones into smaller pieces.
Both techniques have demonstrated high success rates in stone fragmentation and removal,
but debate persists regarding their relative efficacy. Some studies suggest that LL
achieves higher first-attempt stone clearance rates (82-100%) compared to EHL (70.9-75%).
However, EHL is generally more cost-effective and widely available, whereas LL offers
greater precision at a higher procedural cost.
Objective:
This study aims to compare the effectiveness of EHL and LL in the management of difficult
CBD stones through a randomized controlled trial (RCT). The primary outcome is the
success rate of complete stone clearance in the first session. Secondary outcomes include
procedural time, complication rates, and operator satisfaction.
Study Design:
Study Type: Randomized Controlled Trial
Study Population: Patients diagnosed with difficult CBD stones requiring lithotripsy
Intervention Groups:
Group 1: EHL via SpyGlass DS
Group 2: LL via SpyGlass DS
Primary Endpoint: First-session complete stone clearance rate
Secondary Endpoints:
Procedural duration
Post-procedural complications
Operator satisfaction
Significance:
The findings from this study will provide valuable evidence for endoscopists regarding
the optimal lithotripsy method for difficult CBD stones, ultimately improving patient
outcomes and healthcare resource utilization. By identifying the most effective and
efficient technique, this study aims to optimize treatment strategies and enhance
clinical decision-making in endoscopic stone management.